Week of Apr 15th 2018 | FDA Sent These Warning Letters to Pharma Companies

Maybe back to more normal with 16 warning letters posted this week:

  • The Center for Tobacco Products issued 9 warning letters
  • 3 were issued to manufacturers of finished pharmaceuticals (all are OTC manufacturers located outside the US)
  • 2 were issued to compounding pharmacies

So far in CY2018, 14 warning letters out of a total of 33 drug GMP warning letters have been issued to firms that make OTC products.


  • Hanbul Cosmetics Co. Ltd. (Republic of South Korea) received a warning letter on March 29th 2018 based on the outcome an inspection ending December 1st 2017. The firm was placed on import alert 66-40 on March 8th 2018 (21 days before the warning letter). The firm is identified as a manufacturer of OTC products. FDA recommends that the firm hire a CGMP consultant to assist them to come into GMP compliance. Deficiencies include but are not limited to:
    • The firm could not produce data in support of microbiological testing.
    • The firm did not conduct long-term stability studies. Instead, only 6-week accelerated studies were conducted to support the labeled expiry date. Further, the stability determinations do not include an assay determination for the active ingredient.
    • Batch records do not include adequate detail. They do not include weights and measurements of raw materials, start and stop times, and signatures verifying each significant step of manufacturing.
    • And, finally, the firm has not qualified equipment to demonstrate that it is of appropriate design for its intended use.

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  • Luen Wah (HK) Medicine Ltd (Hong Kong) received a warning letter on April 6th 2018 based on the outcome of an inspection ending September 28th 2017. The firm is another manufacturer of OTC products. FDA placed the firm on Import Alert 66-40 on January 18th 2018. FDA suggests that the firm employ a qualified consultant(s) to assist them in coming into GMP compliance.  Deficiencies include but are not limited to:
    • The firm released drug products without testing for identity and strength of each active ingredient. The products were not tested for objectionable micro-organisms and total aerobic count.
    • Incoming APIs and other components are not tested to ensure they meet specifications.
    • There is no stability program and, thus, no data available to support the expiry date on the product label.
    • The firm has not validated manufacturing processes. The firm has not performed process qualification and did not have an ongoing program to monitor process controls.
  • McCallum Manufacturing Ltd (United Kingdom) received a warning letter on April 9th 2018 based on the outcome of an inspection ending July 26th 2017. This is another OTC manufacturer. FDA also suggests the firm should hire a qualified consultant to assist them in coming into GMP compliance. Deficiencies include but are not limited to:
    • The firm does not test whether products meet specifications including identity or strength.
    • The firm did not test incoming raw materials and components for identity but, instead, relied on the information in the vendors CoA.
    • The firm lacks a Quality Control Unit and lacks many of the necessary SOPs required for drug manufactures.
    • The firm lacked validation for drug products.
    • The production and control records do not define and document process parameters. For example, batch records did not include “…identity of the equipment, actual (b)(4) time, temperature, filling and packaging operation steps, and yield percentage”


  • ARJ Infusion Services, Inc. (Lenexa, KS) received a warning letter on April 2nd 2018 based on the outcome of an inspection ending May 25th 2017. The letter identifies 6 GMP deficiencies.
  • Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center (Federal Way, WA) received a warning letter on April 4th 2018 based on the outcome of an inspection ending March 8th 2017. The letter identifies 5 GMP deficiencies. Along with the collection of deficiencies we see for aseptic processing the firm also “…handled hazardous drugs without providing adequate cleaning of equipment and personnel to prevent cross contamination with other products being compounded in your pharmacy. Specifically, an operator was observed blowing air directly onto equipment in a powder hood, dispersing the powdered residue throughout the hood area; failing to clean visible particulate residues from the ceiling of the powder hood; allowing the sleeves of his/her lab coat to come in contact with apparent hazardous drug residue on the surface of the powder hood without changing lab coats between preparations of different products for up to one week; and cleaning the powder hood with tap water and 70% isopropyl alcohol with no data to support the procedure’s effectiveness in neutralizing hazardous drug residue.”

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About the Author

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence.  She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry.  At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers.  She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc.  This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends.  This was an essential service and tool within the Corporate Audit function.

Unger Consulting Inc. | www.ungerconsulting.net | 805.217.9360

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